Flow-Based Tools for Assessment of Aggregation Propensity of Protein Based Pharmaceutical Products
Lead Research Organisation:
University of Leeds
Department Name: Mechanical Engineering
Abstract
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Studentship Projects
| Project Reference | Relationship | Related To | Start | End | Student Name |
|---|---|---|---|---|---|
| BB/P505043/1 | 10/09/2017 | 09/09/2021 | |||
| 1950228 | Studentship | BB/P505043/1 | 30/09/2017 | 31/12/2021 | Ioanna Panagi |
| NE/W503125/1 | 31/03/2021 | 30/03/2022 | |||
| 1950228 | Studentship | NE/W503125/1 | 30/09/2017 | 31/12/2021 | Ioanna Panagi |
| Description | Throughout the complex manufacturing process of biopharmaceuticals, molecules are exposed to forces under flow conditions in combination with the surface interaction through the whole process. Surfaces including bioreactors, filters, syringes, vials etc interact with the molecules thought the manufacture, fill-finish and administration of the final product. A key outcome of the project was that the surface affects significantly into how the molecules behave under these flow conditions and highly influence their propensity to aggregate. |
| Exploitation Route | The identification of surfaces that protect molecules from aggregating is highly applicable in practical perspective. Equipment surfaces, filters, syringes, vials can be treated with the surfaces that are found to be protective in avoiding impacting the biological value of the molecule before reaching to patients. |
| Sectors | Manufacturing including Industrial Biotechology Pharmaceuticals and Medical Biotechnology |
| Description | Surfactant study |
| Organisation | AstraZeneca |
| Department | Research and Development AstraZeneca |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Our previously developed extensional flow device is used to characterise the response of a range of surfactant molecules exposed to extensional flow fields found in the biologics production line. The effect of surfactant is also investigated using analytical methods to determine the best surfactant candidate that could be suitable as a formulation additive. |
| Collaborator Contribution | The collaboration is based on the sharing of model proteins and a range of surfactant molecules (shared by the collaborators) that are used for the conduction of the current study. |
| Impact | This collaboration highlights the importance of interfaces in which biomolecules interact through their manufacture. The combination of interfaces and formulation additives is also commonly found throughout the whole manufacturing process indicating the synergy between interfaces and formulation additives in the protection of the misfolding events of biopharmaceuticals. Some of the interfaces in combination with the formulation additives are found to be important in protecting the structure of these biomolecules. |
| Start Year | 2020 |